Supplier Evaluation Procedure Template (ISO 13485, Medical Device)

Description

Why it is useful

How to use it

1. You may use this procedure template in your Quality Management System after adapting it to your needs and removing the informative text.
2. Use the template as an inspiration while authoring your own procedure.
3. Use the template as a benchmark to check your own existing procedure.

As a general remark, throughout this procedure, the term “hazard traceability matrix” is used for the document containing the table with risks. Some would refer to this as “the risk analysis”, or “the FMEA”. Since both “risk analysis” and “FMEA” have other meanings/definitions from standards, they are not used for the hazard traceability matrix in this procedure.

In general, you can change who is responsible for what throughout this procedure. Nothing specifically requires QA, for example, to own this process.

In this template, instructions and/or explanations are included using blue italic texts such as these. Instructions and explanations should be removed before using the document. All texts that are not blue are example texts that can and should be edited by you. Texts that most certainly should be replaced or updated are identified by the { and } characters. They should be removed, and the example text customized to work with the current project.

In general, you can change who is responsible for what throughout this procedure.

In this template, instructions and/or explanations are included using blue italic texts such as these. Instructions and explanations should be removed before the review of the document.

All texts that are not blue are example texts that can and should be edited by you and tailored to your situation.

Texts that most certainly should be replaced or updated are identified by the { and } characters. They should be removed and the example text updated to suit your situation.

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